NCT01206790

Brief Summary

Posttraumatic stress disorder (PTSD) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. Research, including our own findings, indicates immunological alterations in PTSD patients. The aim of this study is to investigate whether alterations in the immune system of PTSD patients are reversible through a trauma-specific short-term therapy (Narrative Exposure Therapy).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.9 years

First QC Date

September 21, 2010

Last Update Submit

February 21, 2012

Conditions

PTSD

Keywords

PTSDNarrative Exposure Therapytorture victimsimmune system

Outcome Measures

Primary Outcomes (1)

  • PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)

    4 month after completion of treatment

Secondary Outcomes (1)

  • changes in immunological parameters

    4 months after completion of treatment

Study Arms (2)

Narrative Exposure Therapy (NET)

EXPERIMENTAL
Behavioral: NET

Waitinglist Control Group

NO INTERVENTION

Interventions

NETBEHAVIORAL

Narrative Exposure Therapy for traumatized survivors of organized violence

Narrative Exposure Therapy (NET)

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • PTSD diagnosis
  • experiences of organized violence/torture

You may not qualify if:

  • psychotic disorder
  • chronic inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz, Department of Psychology

Konstanz, 78467, Germany

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Iris-Tatjana Kolassa, Prof. Dr.

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Iris-Tatjana Kolassa

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

June 1, 2009

Primary Completion

May 1, 2011

Study Completion

January 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

DE(1)